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Abbreviation: RJPS Vol No: 14 Issue No: 4 eISSN: pISSN:2249-2208
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Stability Indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) Method for the Analysis of Azelnidipine in Bulk Drug and Pharmaceutical Dosage Forms
Prakash S Sarsambi1, G Kaverii2, J Preetii3, A Rameshi3, B Sharanagoudi4, Bebii4*
1. Professor and HOD, Department of Pharmaceutical Analysis, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
2. Research Scholar Department of Pharmaceutical Analysis, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
3. Research Scholar Department of Pharmacology, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
4. Assistant Professor, Department of Pharmaceutical Chemistry, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
2. Research Scholar Department of Pharmaceutical Analysis, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
3. Research Scholar Department of Pharmacology, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
4. Assistant Professor, Department of Pharmaceutical Chemistry, HKES’s Mathoshree Taradevi Rampure Institute of Pharmaceutical Science, Sedam Road, Kalaburagi, Karnataka-585105, India.
Aim/ Objective: The principle goal of the study was to develop a highly sensitive, precise, rapid and un-complicated high performance reversed phase liquid chromatographic method for the quantitative analysis of Azelnidipine in bulk drug and pharmaceutical dosage forms.
Methods: This analysis utilized an Inertsil-C18 ODS. The mobile phase comprised of acetonitrile and methanol in the ratio of 30:70 v/v respectively and was delivered at the flow rate of 1.0 mL/min and injection volume was 20µl. Detection was carried out by UV Spectroscopy at the wavelength of 280nm.The retention time of Azelnidipine was found to be 6.490min. the calibration plots showed within the concentration range of 20-80ppm. The value of correlation coefficient was found to be 0.9990.
Result: The calibration plots showed good linear relationship within the specified concentration the value of correlation coefficient was found to be 0.9990. The test method's great accuracy was demonstrated by the finding that the intra- and inter-day variance was less than 1%showing high precision of the assay method
Conclusion:The newly developed method for the quantitative analysis of Azelnidipines is a highly sensitive, precise, rapid and un-complicated.considering its reliable characteristics, it may be employed for periodic testing in pharmaceutical and bulk drug formulations, which helps with quality control in the manufacturing and assessment of Azelnidipine products.
Methods: This analysis utilized an Inertsil-C18 ODS. The mobile phase comprised of acetonitrile and methanol in the ratio of 30:70 v/v respectively and was delivered at the flow rate of 1.0 mL/min and injection volume was 20µl. Detection was carried out by UV Spectroscopy at the wavelength of 280nm.The retention time of Azelnidipine was found to be 6.490min. the calibration plots showed within the concentration range of 20-80ppm. The value of correlation coefficient was found to be 0.9990.
Result: The calibration plots showed good linear relationship within the specified concentration the value of correlation coefficient was found to be 0.9990. The test method's great accuracy was demonstrated by the finding that the intra- and inter-day variance was less than 1%showing high precision of the assay method
Conclusion:The newly developed method for the quantitative analysis of Azelnidipines is a highly sensitive, precise, rapid and un-complicated.considering its reliable characteristics, it may be employed for periodic testing in pharmaceutical and bulk drug formulations, which helps with quality control in the manufacturing and assessment of Azelnidipine products.
Prospective Observational Study of Antimicrobials Utilization Prescriptions Audit in Pediatric Patients at District General Hospital in Maharashtra
Mulchand Shende*, Ankush Racherlawar, Chetan There, Sandip Bhurke>
Department of Pharmacy Practice, Government College of Pharmacy, Kathora Naka, Amravati, Maharashtra, India.
Background: Antimicrobials are essential for treating many illnesses in pediatric patients, but the most improperly prescribed ones can increase antibacterial resistance and negatively impact patients' quality of life.
Objectives: This study aimed to evaluate the prescribing pattern of antimicrobials for children using WHO core prescribing indicators and audit its rationale.
Methods: A prospective observational study was conducted over six months in the pediatric department of a district hospital in Amravati. Data collected included demographic details, clinical diagnosis, antimicrobial usage, total number of prescribed drugs, duration of hospital stay, and treatment details. The data were recorded in a spreadsheet and analyzed using GraphPad Prism version 10.2.3.
Results: A total of 209 patients were enrolled, with 53.58% being male and a mean age of 5.47±3.13 years. Antimicrobials were prescribed throughout the study, with 72.30% receiving combination therapy- 43.06% on two-drug and 25.83% on three-drug regimens. The average of 2.08 drugs per patient indicates polypharmacy. Among 435 antimicrobials, 71.24% were injectables, 28.27% oral, and amoxicillin-clavulanic acid (24.59%) was the most prescribed. Irrational prescriptions based on use, dose, and frequency accounted for 27.27%, 5.74%, and 2.87%, respectively. A significant correlation (P < 0.05) was found between patient age and the number of antimicrobials prescribed.
Conclusions: Penicillin's β-lactamase inhibitor is the most often prescribed class of antibiotics. Given the increased usage of injectable drugs, the antimicrobial prescribing pattern deviates from WHO guidelines.
Objectives: This study aimed to evaluate the prescribing pattern of antimicrobials for children using WHO core prescribing indicators and audit its rationale.
Methods: A prospective observational study was conducted over six months in the pediatric department of a district hospital in Amravati. Data collected included demographic details, clinical diagnosis, antimicrobial usage, total number of prescribed drugs, duration of hospital stay, and treatment details. The data were recorded in a spreadsheet and analyzed using GraphPad Prism version 10.2.3.
Results: A total of 209 patients were enrolled, with 53.58% being male and a mean age of 5.47±3.13 years. Antimicrobials were prescribed throughout the study, with 72.30% receiving combination therapy- 43.06% on two-drug and 25.83% on three-drug regimens. The average of 2.08 drugs per patient indicates polypharmacy. Among 435 antimicrobials, 71.24% were injectables, 28.27% oral, and amoxicillin-clavulanic acid (24.59%) was the most prescribed. Irrational prescriptions based on use, dose, and frequency accounted for 27.27%, 5.74%, and 2.87%, respectively. A significant correlation (P < 0.05) was found between patient age and the number of antimicrobials prescribed.
Conclusions: Penicillin's β-lactamase inhibitor is the most often prescribed class of antibiotics. Given the increased usage of injectable drugs, the antimicrobial prescribing pattern deviates from WHO guidelines.
A Simple and Validated HPTLC Method for Eugenol Isolated from Syzygium Aromaticum L
Munishama Gowda Y N1, Chaluvaraju K C1*, S Ramachandra Setty2
1. Department of Pharmaceutical Chemistry, Government College of Pharmacy, Bengaluru, Karnataka, India
2. Research and Development, Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru, India
2. Research and Development, Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru, India
Background: Syzygium aromaticum L. buds are the primary source of eugenol (2-methoxy-4-(prop-2-en-1-yl) phenol), a naturally occurring phenylpropanoid. It exhibits anticancer, antioxidant, antibacterial, antifungal, and anti-inflammatory properties. Its quantification is essential for quality control in pharmaceutical and industrial applications.
Objectives: This study aimed to develop and validate a rapid, efficient, and precise High-Performance Thin-Layer Chromatography (HPTLC) method for estimating eugenol isolated from S. aromaticum L. buds.
Methods: The structure of eugenol was confirmed using thin-layer chromatography (TLC), Fourier Transform Infrared Spectroscopy (FTIR), Proton Nuclear Magnetic Resonance (1H NMR), and Gas Chromatography-Mass Spectrometry (GC-MS). HPTLC analysis employed a mobile phase comprising toluene, ethyl acetate, and glacial acetic acid in a 7.8:2.2:0.1 (v/v/v) ratio. Densitometric scanning was performed in the absorbance mode at 282 nm. The method was validated by International Conference on Harmonization (ICH) guidelines.
Results: The developed HPTLC method was validated for specificity, precision, linearity, accuracy, sensitivity, and robustness.
Conclusion: This validated HPTLC method provides a reliable and precise approach for routine quality control of eugenol in raw materials and formulations. It ensures product quality, safety, and consistency in pharmaceuticals, cosmetics, essential oils, and industrial applications. The method supports regulatory compliance and facilitates innovation in the therapeutic and commercial use of eugenol-based products.
Objectives: This study aimed to develop and validate a rapid, efficient, and precise High-Performance Thin-Layer Chromatography (HPTLC) method for estimating eugenol isolated from S. aromaticum L. buds.
Methods: The structure of eugenol was confirmed using thin-layer chromatography (TLC), Fourier Transform Infrared Spectroscopy (FTIR), Proton Nuclear Magnetic Resonance (1H NMR), and Gas Chromatography-Mass Spectrometry (GC-MS). HPTLC analysis employed a mobile phase comprising toluene, ethyl acetate, and glacial acetic acid in a 7.8:2.2:0.1 (v/v/v) ratio. Densitometric scanning was performed in the absorbance mode at 282 nm. The method was validated by International Conference on Harmonization (ICH) guidelines.
Results: The developed HPTLC method was validated for specificity, precision, linearity, accuracy, sensitivity, and robustness.
Conclusion: This validated HPTLC method provides a reliable and precise approach for routine quality control of eugenol in raw materials and formulations. It ensures product quality, safety, and consistency in pharmaceuticals, cosmetics, essential oils, and industrial applications. The method supports regulatory compliance and facilitates innovation in the therapeutic and commercial use of eugenol-based products.
Harnessing Azadirachta indica Fruit Mucilage in Mucoadhesive Microspheres for Effective Viral Infection Mitigation: Design-Expert Guided Optimization
E Satheesh Kumar1, Hindustan Abdul Ahad1*, Giridhar B2
Department of Pharmaceutics, R R College of Pharmacy, Chikkabanavara, Bengaluru, 560090, Karnataka, India
2Department of Quality Assurance, Himalaya Wellness Company, Tumkur Road, Makali, Bengaluru, Karnataka, India
2Department of Quality Assurance, Himalaya Wellness Company, Tumkur Road, Makali, Bengaluru, Karnataka, India
Aim: The research aimed to investigate the enhanced mucoadhesive properties of Azadirachta indica fruit mucilage (AIFM) when incorporated into mucoadhesive microspheres containing Acyclovir as a representative model drug.
Methods: Nine formulations of mucoadhesive microspheres were created, incorporating Carbopol-934P and different ratios of Azadirachta indica fruit mucilage. A central composite design was employed using Design-Expert software to assess the influence of independent variables (concentrations of polymers) on the dependent variable (mucoadhesive strength). The microspheres underwent compatibility studies and various physical evaluations, including analysis of Acyclovir content and its discharge kinetics.
Results: The study observed that the mucoadhesion strength of the microspheres increased as the levels of Azadirachta indica fruit mucilage in the formulations increased. Additionally, formulations with lower levels of AIFM exhibited greater drug discharge at the 10th h mark. Conversely, higher AIFM concentrations in the formulations acted as retarding agents for drug discharge, leading to a slight reduction in the discharged amount of drug.
Conclusion: This experiment highlights that the mucoadhesive drug delivery system incorporating Acyclovir using Carbopol 934P along with Azadirachta indica fruit mucilage successfully fulfills the requirement for gastro retention. This approach proves to be an effective strategy for delivering drugs specifically to the stomach.
Methods: Nine formulations of mucoadhesive microspheres were created, incorporating Carbopol-934P and different ratios of Azadirachta indica fruit mucilage. A central composite design was employed using Design-Expert software to assess the influence of independent variables (concentrations of polymers) on the dependent variable (mucoadhesive strength). The microspheres underwent compatibility studies and various physical evaluations, including analysis of Acyclovir content and its discharge kinetics.
Results: The study observed that the mucoadhesion strength of the microspheres increased as the levels of Azadirachta indica fruit mucilage in the formulations increased. Additionally, formulations with lower levels of AIFM exhibited greater drug discharge at the 10th h mark. Conversely, higher AIFM concentrations in the formulations acted as retarding agents for drug discharge, leading to a slight reduction in the discharged amount of drug.
Conclusion: This experiment highlights that the mucoadhesive drug delivery system incorporating Acyclovir using Carbopol 934P along with Azadirachta indica fruit mucilage successfully fulfills the requirement for gastro retention. This approach proves to be an effective strategy for delivering drugs specifically to the stomach.